Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.

Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs). Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.

Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.

HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan's hazard control, or maintaining records as required by 21 CFR Part 123

Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food. Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.

These violations are nearly identical to the most common violations cited in FY 2016 and FY 2015. Food facilities should use this pattern to anticipate the areas in their daily operations that may require further review before an FDA inspection.

The 2017 list is the first to include violations related to FDA's Preventive Controls and Foreign Supplier Verification Program (FSVP) rules, which had compliance deadlines in 2017. Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times. With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.

FDA to Focuses on More Efficient and Effective Food Recalls, Gottlieb Says

Editor's note: On Dec. 26, FDA Commissioner Scott Gottlieb issued the following statement, which outlined improvements in the recall process and discussed new policies being considered to support more efficient and effective food recalls.

One of our most important jobs at the U.S. Food and Drug Administration is ensuring the safety of the U.S. food supply. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. If foodborne illness has already occurred, we also must act quickly to keep more people from becoming ill. The re-issued, final version of the report by the Office of the Inspector General (OIG), which examined our food recall practices over the time period from Oct. 1, 2012 to May 4, 2015, raised some significant concerns for me. While the FDA has addressed many of the findings after the draft version was first released in 2016, we still have more work to do. I take these obligations very seriously. Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission.

The FDA has authority to act in a variety of ways when it is made aware of an unsafe food product. But often the fastest and most efficient way to ensure unsafe foods are recalled quickly is by working directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on. Among other steps, I want to do even more to make sure that consumers have the information they need to avoid hazardous products that are the subject of recalls, or to seek assistance if they may have been exposed to a recalled food product. The FDA is exploring various ways to better accomplish this goal. Among other steps, the agency will issue guidance on recall communications in the first half of 2018. As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product. If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.

Fortunately, most companies are cooperative and rapidly initiate a voluntary recall of a hazardous food product. On average, the recall occurs within four calendar days of the problem being discovered. These recalls are typically done in close coordination with FDA’s food program staff. Sometimes a company discovers the problem and initiates the recall, while other times a company acts after the FDA brings a concern to their attention. When the company does not cooperate, we have the authority to mandate certain product recalls thanks to the 2011 Food Safety Modernization Act. Regardless of how the recall occurs, the FDA oversees the company's recall strategy and assesses the adequacy of the recall.

Sometimes the recall process does not work as well as we’d like. As part of the OIG report, last year, the OIG reviewed a selective sample of 30 food recalls initiated from 2012 to 2015, including some very challenging ones, which occurred over this 3-year period. The OIG made a series of recommendations on how the agency might improve its management of recalls. A lot has changed since that timeframe when it comes to our food safety practices. But I know that much work remains to be done if we’re going to provide the highest assurance of safety. We’ve taken the OIG recommendations to heart, and worked quickly to put in place measures to address the proposals that the OIG outlined. One of the most significant steps we took in April of last year was to establish a team of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem if it isn’t clear. The team meets at least weekly and makes recommendations about what actions to take and how to make sure they occur.

Over the past year, this team of senior leaders, called the SCORE team (which stands for “Strategic Coordinated Oversight of Recall Execution”) has made a big difference in these situations. They’ve been involved in cases that range from lead contamination of a dietary supplement, Salmonella contamination of powdered milk, E. coli O157:H7 in soy nut butter and Listeria in hummus, soft cheese and smoked fish. In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or helped to expedite the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food to the marketplace. In addition to the establishment of SCORE, we’ve put in place several additional procedural and policy changes. Last year, after a comprehensive review of our recall process, we developed a new strategic plan that outlines actions to improve FDA’s recall management. The plan helps to standardize how the FDA assesses a company’s recall efforts, and provides additional training to our staff involved in recall efforts so they can properly monitor and assess the effectiveness of a recall.

Building on these early efforts, we intend to say more in early 2018 on additional policy steps we’ll take as part of a broader action plan to improve our oversight of food safety and how we implement the recall process. We’re looking at ways to improve the timeliness and scope of information we provide to the public about recalls of FDA regulated foods. I believe that consumers should have the actionable information they need to avoid hazardous products that are the subject of recalls, or to seek assistance if they may have already been exposed to a recalled food product. We’re committed to continuously improving our policies and practices to ensure that recalls are initiated, overseen, and completed promptly and effectively to best protect consumers. Let me assure you that we will use all the tools at our disposal to make sure that we carry through on this commitment.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Long Island Iced Tea Corp to Refocus and Rename as Long Blockchain Corp

The parent company of Long Island Iced Tea Corp. is shifting its primary corporate focus toward the exploration of and investment in opportunities that leverage the benefits of blockchain technology. In connection with the shift in strategic direction, the company is changing its name from “Long Island Iced Tea Corp.” to “Long Blockchain Corp.” and has reserved the web domain www.longblockchain.com.

The company intends to request Nasdaq to change its trading symbol in connection with the name change. It will continue to operate Long Island Brand Beverages as a wholly-owned subsidiary and maintain the focus of this business on the ready-to-drink segment of the beverage industry, specifically, premium, ‘better-for-you’ brands marketed at an affordable price.

In conjunction with the shift in business strategy, the company has submitted a request to the Securities and Exchange Commission to withdraw its previously filed S-1 registration statement relating to a proposed underwritten public offering, which was filed November 11, 2017.

Blockchain acts as a public, decentralized ledger. This ledger provides a single, unified source of data, creating a clearer audit trail and consistency across parties. The Company believes that emerging blockchain technologies are creating a fundamental paradigm shift across the global marketplace, with far reaching applications across all industries from financial services (smart settlements) to consumer packaged goods (supply chain verification) to healthcare (electronic medical records).

The company is already in the preliminary stages of evaluating specific opportunities involving blockchain technology. The discussions are only in the preliminary stages but indicate the areas of focus for the company. These opportunities include potential partnerships, investments or acquisitions involving a blockchain software developer building blockchain infrastructure for the financial services industry; a London-based FCA regulated, institutional provider of FX services that is building multiple blockchain and digital crypto currency technology solutions for global financial markets; a new smart contract platform for building decentralized applications that provides scalability beyond currently available options.

However, the company does not have an agreement with any of these entities for a transaction and there is no assurance that a definitive agreement with these, or any other entity, will be entered into or ultimately consummated.

“We view advances in blockchain technology as a once-in-a-generation opportunity, and have made the decision to pivot our business strategy in order to pursue opportunities in this evolving industry,” said CEO Philip Thomas. “We are committed to enhancing shareholder value and believe that our new focus is the best path towards this goal. We will, in the coming weeks and months, be taking a series of steps related to our efforts to assemble a world-class team of industry professionals to help us realize this vision. We are pursuing our new direction in a thoughtful and deliberate manner.

“I am incredibly proud of what we have accomplished in the beverage industry and we are committed to growing our business both on a national and international scale,” Thomas added. “I want to assure our beverage industry customers, suppliers, and partners of our continuing support of the Long Island Iced Tea portfolio of beverages. Your support over the years has helped to drive our growth and elevate our brand, and we remain committed to maintaining and fostering these relationships.”

Greenyard in Advanced Negotiations to Acquire Dole

On December 19, Belgium-based Greenyard announced that it is in advanced negotiations to acquire Dole Food Company, Inc.

At this stage, a definitive agreement has not been reached, and there can be no assurance that these negotiations will culminate in a transaction between the two companies. Greenyard has secured appropriate financing, and is confident in its ability to complete the transaction with a balanced financing approach should a definitive agreement be reached.

Greenyard stated that it will provide further comment related to this potential combination when there is news to share.

Greenyard is a global provider of fresh and prepared fruits and vegetables and growing media. It has more than 8,000 employees in 25 countries.

Sales and Distribution of Antimicrobial Drugs for Food-Producing Animals Declined in 2016

FDA’s annual report summarizing sales and distribution data for all antimicrobial drugs approved for use in food-producing animals shows that antimicrobial sales decreased from 2015 to 2016. Domestic sales and distribution of all antimicrobials decreased by 10 percent and domestic sales and distribution of medically important antimicrobials decreased by 14 percent. In previous years (between 2009 and 2015), overall sales volumes increased annually.

FDA has published annual summary reports since 2009 in compliance with requirements established by Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). ADUFA 105 requires antimicrobial drug sponsors to report to the FDA on an annual basis the amount of antimicrobial drugs sold or distributed for use in food-producing species during the prior year. ADUFA 105 also requires FDA to issue annual summary reports of sales and distribution data collected from sponsors each year, by antimicrobial class for classes represented by three or more distinct sponsors, and to provide those summaries to the public.

In May 2016, the agency issued a final rule revising its annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys). The 2016 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals is the first annual summary report to include these species estimates. FDA anticipates that having these additional species-specific data will improve the agency’s understanding of sales and distribution data.

Sales data provide insight regarding antimicrobial drugs entering the marketplace, but additional sources of information should be considered when assessing progress of efforts to foster judicious antimicrobial use, including actual use data, animal demographics and animal health data, and data on resistance. DA continues to work with federal, academic, and industry partners to obtain more information about how, when, and why animal producers and veterinarians use medically important antimicrobial drugs in food-producing animals.